Shots:

• The submission is based on P-lll EMERGE and ENGAGE study assessing aducanumab vs PBO in patients with AD. The studies evaluate the efficacy of monthly doses of aducanumab in reducing cognitive and functional impairment
• The secondary objectives of the study were to assess the effect of monthly doses of aducanumab on the clinical decline as measured by MMSE- ADAS-Cog 13 & ADCS-ADL-MCI. MHLW will review the application through the standard review process
• Aducanumab is an investigational mAb that is under the US FDA’s PR with an anticipated PDUFA date as Mar 7- 2021 and is also under review with the EMA

 ­ Ref: GlobeNewswire | Image: Biogen